Mini-project
Pharma & Life Sciences
Shelf-life prediction from stability studies
Estimate a medicine's shelf life from stability readings at different storage conditions.
The brief
A label date needs evidence. Using assay readings from long-term and accelerated stability studies, fit the decay, apply the Arrhenius relation to link temperature to rate, and estimate the shelf life with a confidence limit as the usual guideline asks. Good looks like: the right regression and confidence bound, an Arrhenius plot, and a plain statement of the shelf life and what would change it.
What you will build
- Read the stability guideline on how shelf life is set
- Load assay data for each condition and time
- Fit the decay order and rate for each temperature
- Build the Arrhenius plot and extrapolate
- Calculate shelf life with a 95 percent bound
- Write the conclusion for a regulatory file
Free, open data to build it with
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